Lesion-Based Evaluation Predicts Treatment Response to Lenvatinib for Radioactive Iodine-Refractory Differentiated Thyroid Cancer: A Korean Multicenter Retrospective Study.
基于病变的评估预测 Lenvatinib 治疗放射性碘难治性分化型甲状腺癌的治疗反应: 一项韩国多中心回顾性研究。
Korea lenvatinib lesion-based evaluation progressive disease thyroid cancer
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摘要

                        Background:
                     Lenvatinib, a tyrosine kinase inhibitor (TKI) recently approved for treating radioactive iodine-refractory differentiated thyroid cancer, has been shown to delay disease progression and provide meaningful benefit for overall survival (OS). However, there is no predictive marker for response to lenvatinib before initiating treatment. We comprehensively analyzed clinical and radiological parameters to predict response to lenvatinib using lesion-based assessments. 
                        Methods:
                     Medical records were collected from 67 patients treated with lenvatinib in 11 referral hospitals across Korea from June 2015 to December 2017. Up to 96 measurable lesions, defined as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, were evaluated serially until progressive disease (PD) occurred, and tumor doubling time (TDT) was calculated based on changes between historical computed tomography (CT) scans and baseline CT scans performed at treatment initiation. 
                        Results:
                     Excluding patients with anaplastic thyroid cancer, no thyroidectomy, nontarget lesions only, or treatment periods of <1 month, 57 patients were analyzed, of whom 7 (12.2%) were TKI-naive. The median progression-free survival was 5.1 months (95% confidence interval [CI], 4.4-9.5), the median OS was 19.3 months (95% CI 12.4-not reached), the mean duration of response was 6.0 ± 4.4 months, and the objective response rate was 38%. In lesion-based assessments, 31 lesions (32.2%) with significant tumor shrinkage (complete remission or partial response) were significantly associated with shorter TDT (<12 months; p = 0.02). Patients with rapidly PD with a shorter initial TDT (<6 months) were more likely to respond to lenvatinib (p = 0.03). Patients exposed to lenvatinib at an average of ≥16 mg per day, or who were TKI-naive before treatment with lenvatinib, had a lower risk of progression; however, the risk reduction did not reach statistical significance (daily dosage p = 0.07, TKI exposure p = 0.09). 
                        Conclusions:
                     TDT calculations at the beginning of treatment and lesion-based tumor assessment may help identify potential responders to lenvatinib therapy and predict therapeutic responses.

译文

背景:
Lenvatinib 是一种酪氨酸激酶抑制剂 (TKI),最近被批准用于治疗放射性碘难治性分化型甲状腺癌,已被证明可以延缓疾病进展并为总生存期 (OS) 提供有意义的益处。然而,在开始治疗之前,没有对 lenvatinib 反应的预测指标。我们综合分析了临床和影像学参数,使用基于病变的评估来预测对 lenvatinib 的反应。
方法:
从 2015年6月到 2017年12月,在韩国 11 家转诊医院收集了 67 名接受 lenvatinib 治疗的患者的病历。根据实体肿瘤 (RECIST) 1.1 版的反应评估标准定义的多达 96 个可测量的病变被连续评估,直到进展性疾病 (PD) 发生,以及肿瘤倍增时间 (TDT) 根据治疗开始时进行的历史计算机断层扫描 (CT) 扫描和基线 ct扫描之间的变化进行计算。
结果:
排除未分化型甲状腺癌、未行甲状腺切除术、仅行非靶区病变或治疗时间小于 1 个月的患者,分析了 57 名患者,其中 7 名 (12.2%) 患者 TKI 未发生。中位无进展生存期为 5.1 个月 (95% 置信区间 [CI],4.4-9.5),中位 OS 为 19.3 个月 (95% CI 12.4-未达到), 平均反应持续时间为 6.0 ± 4.4 个月,客观反应率为 38%。在基于病变的评估中,31 个具有显著肿瘤缩小 (完全缓解或部分缓解) 的病变 (32.2%) 与较短的 TDT (<12 个月; p = 0.02) 显著相关。初始 TDT 较短 (<6 个月) 的快速 PD 患者更有可能对 lenvatinib 有反应 (p = 0.03)。暴露于平均每天 ≥ 16 毫克的 lenvatinib 的患者,或者在使用 lenvatinib 治疗前没有接受 TKI 治疗的患者,其进展风险较低; 然而, 风险降低没有达到统计学意义 (日剂量 p = 0.07,TKI 暴露 p = 0.09)。
结论:
治疗开始时的 TDT 计算和基于病变的肿瘤评估可能有助于确定 lenvatinib 治疗的潜在应答者并预测治疗反应。

Lenvatinib

肿瘤 乐伐替尼、肝癌 药物
概述  :  

仑伐替尼,又译为:乐伐替尼,研发代号:E7080,由日本卫材(Eisai)公司研发,是一种多靶点受体酪氨酸激酶(RTK)抑制剂,可抑制VEGFR1、VEGFR2和VEGFR3,亦可抑制其他与病理性新生血管、肿瘤生长及癌症进展相关的RTK,包括成纤维细胞生长因子受体FGFR1、2、3、4和血小板衍化生长因子受体α,KIT及RET。 2015年美国FDA和欧洲药品管理局EMA批准仑伐替尼用于治疗侵袭性、局部晚期或转移性分化型甲状腺癌。2016年美国FDA和欧

lenvatinib

释    义   n. 乐伐替尼(一种酪氨酸激酶受体抑制剂)

例    句   Lenvatinib is an oral multi-kinase inhibitor approved for the treatment of adults with progressive, locally advanced or metastatic, differentiated thyroid carcinoma refractory to radioactive iodine.仓伐替尼是一种口服多激酶抑制剂,被批准用于治疗进展性、局部进展性或转移性、对放射性碘难治的分化型甲状腺癌。

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